Quantification of narcoleptic drug, Modafinil, by high performance liquid chromatographic method

Abstract

A stability indicating HPLC method was developed and validated for modafinil quantification in bulk and tablet dosage forms. Aligent zorebax SB C18 analytical column (250 mm x 4.6 mm, 5 μm particle size) was used with mobile phase consisting of 0.1 M sodium dihydrogen phosphate and methanol in ratio 60:40 (v/v), flow-rate 1.0 ml/min, UV-detection at 230 nm and controlled temperature at 30°C. The linearity was found in the concentration range of 5-150 μg/ml. The method was validated as per the ICH guidelines. The drug was exposed to acidic, basic, oxidation, photo degradation and dry heat conditions. As the developed method can efficiently separate the modafinil from its degradation products, it can be employed as stability-indicating method.

Key words: Modafinil, stability indicating HPLC, method development, validation, tablet dosage forms